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FDA 510(k)

TRAPIS (TRANSPERINEAL PROSTATE IMPLANT SIMULATOR), VERSION 1.5

K-Number: K990475 · 1999-11-18

ApplicantKps & Assoc., Inc.
Decision Date1999-11-18
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TRAPIS (TRANSPERINEAL PROSTATE IMPLANT SIMULATOR), VERSION 1.5 is the device name listed in this FDA 510(k) record. The listed applicant is Kps & Assoc., Inc.. It received FDA 510(k) clearance on 1999-11-18 under 510(k) number K990475. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRAPIS (TRANSPERINEAL PROSTATE IMPLANT SIMULATOR), VERSION 1.5?

TRAPIS (TRANSPERINEAL PROSTATE IMPLANT SIMULATOR), VERSION 1.5 is a medical device that received FDA 510(k) clearance on 1999-11-18. The listed applicant is Kps & Assoc., Inc.. The 510(k) number is K990475.

When did TRAPIS (TRANSPERINEAL PROSTATE IMPLANT SIMULATOR), VERSION 1.5 receive FDA 510(k) clearance?

TRAPIS (TRANSPERINEAL PROSTATE IMPLANT SIMULATOR), VERSION 1.5 received FDA 510(k) clearance on 1999-11-18, under 510(k) number K990475.

Who is the listed applicant for TRAPIS (TRANSPERINEAL PROSTATE IMPLANT SIMULATOR), VERSION 1.5?

The FDA 510(k) record lists Kps & Assoc., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRAPIS (TRANSPERINEAL PROSTATE IMPLANT SIMULATOR), VERSION 1.5?

The FDA product code for TRAPIS (TRANSPERINEAL PROSTATE IMPLANT SIMULATOR), VERSION 1.5 is MUJ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: MUJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260750Virtual Cone (1.0)Varian Medical Systems, Inc.K253050RadOncAIInformaiK260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.K252784eXaSkin PlusAnatomical Geometry S.L.K253078ART.1-USSeetreat Pty, Ltd.K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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